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lifeline tle endocardial pacing lead
Intermedics
Summary: The Lifeline TLE Endocardial Pacing Lead is a cardiac device used for pacing the heart. It is primarily utilized by cardiologists to manage patients with arrhythmias requiring pacing support.
FDA Clearance Information
Pathway
510K
Number
K792604 ↗
Decision Date
December 31, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline TLE Endocardial Pacing Lead was cleared through the FDA 510k pathway on December 31, 1979. Manufactured by Intermedics, it is classified as a Class 3 device under product code DTB.
What It Is
The Lifeline TLE Endocardial Pacing Lead is a medical device designed to provide electrical pacing to the heart. It is implanted endocardially, meaning it is placed inside the heart chambers, typically via a transvenous approach. The device helps maintain an adequate heart rate by delivering electrical impulses when the heart's natural pacemaker fails to do so.
Clinical Applications
This device is commonly used in cardiology, particularly in patients with bradycardia or heart block who require pacing support. It is typically used in hospital settings, including operating rooms and cardiac catheterization labs, and is suitable for adult patients who need long-term pacing therapy.
Indications for Use
The Lifeline TLE Endocardial Pacing Lead is indicated for patients who require cardiac pacing due to conditions like symptomatic bradycardia or heart block. It is used in patients whose natural heart rate is insufficient to meet their physiological needs.
Practical Considerations
The device is available in various lengths to accommodate different patient anatomies and is compatible with standard pacemaker generators. Proper implantation technique is crucial to ensure lead stability and optimal pacing function.
Frequently Asked Questions
What is the Lifeline TLE Endocardial Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
It is indicated for patients requiring pacing support due to conditions like symptomatic bradycardia or heart block.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.